| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00780-3 |
| Product Name/Description |
Access Immunoassay Systems Access Folate Calibrators, Part numbers: A14207, A98033. An in vitro diagnostic medical device (IVD)
Part Number: A14207
Lot Numbers: 112788 (Expiry Date 30 JUN 2012); 115741 (31 AUG 2012); 118917 (31 OCT 2012)
Part Number: A98033
Lot Numbers: 122651 (31 JUL 2012); 123635 (30 SEP 2012); 219962 (31 OCT 2012) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has confirmed that the stability, while frozen, for the Access Folate calibrators may produce falsely elevated results which could mask a folate deficiency. Product Number A14207 may experience this issue at 12 months, and Product Number A98033 at 6 months. |
| Recall Action |
Recall |
| Recall Action Instructions |
Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |